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Last Updated: August 10, 2020

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Bepotastine besilate - Generic Drug Details

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What are the generic sources for bepotastine besilate and what is the scope of patent protection?

Bepotastine besilate is the generic ingredient in two branded drugs marketed by Apotex, Mylan, and Bausch And Lomb Inc, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bepotastine besilate has eleven patent family members in eight countries.

There are seven drug master file entries for bepotastine besilate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for bepotastine besilate

Identify potential brand extensions & 505(b)(2) entrants

Dong-A ST Co., Ltd.N/A
Dong-A ST Co., Ltd.Phase 1
Daewoong Pharmaceutical Co. LTD.Phase 1

See all bepotastine besilate clinical trials

Generic filers with tentative approvals for BEPOTASTINE BESILATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1.5%SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bepotastine besilate
Paragraph IV (Patent) Challenges for BEPOTASTINE BESILATE
Tradename Dosage Ingredient NDA Submissiondate
BEPREVE SOLUTION/DROPS;OPHTHALMIC bepotastine besilate 022288 2013-09-09

US Patents and Regulatory Information for bepotastine besilate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 206220-001 Mar 18, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Bausch And Lomb Inc BEPREVE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 022288-001 Sep 8, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apotex BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 206066-001 Mar 5, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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